Formulations And Treatments For Trichology

ABSTRACT

a formulation for trichological treatment of a patient including, in a dosage in the range of 3 g to 8 g: phytosterols in the range of 200 mg to 2500 mg; the quantitative equivalent of  Polygonum multiflorum  root 4:1 in 70% EW in the range of 600 mg to 2600 mg; methylsulfonylmethane in the range of 500 mg to 2000 mg; and bovine colostrum in the range of 500 m to 2000 m.

FIELD OF INVENTION

THIS INVENTION relates to formulations and treatments for trichology.The invention is primarily directed to formulations and treatments forreduction of hair loss and/or hair regrowth typically exhibited in adulthumans having a condition sometimes referred to alopecia. Although thecondition is more prevalent in human males and is sometimes referred toas male pattern alopecia, the invention is applicable to treatment ofboth male and female alopecia.

BACKGROUND ART

Herbal extracts and formulations have been suggested for thetrichological treatment of humans, particularly males, but notexclusively so. Efficacy varies from nil to some reduction in hair lossand/or noticeable hair regrowth on the heads of patients. However, theinteraction of the constituent compounds in such formulations with oneanother is little understood. The respective modes of action of suchformulations are quite diverse. Generally, such treatments are eithertopical or systemic.

The term alopecia is used in the art generally to refer to allconditions of baldness, including partial baldness, and the termalopecia is used in this specification to have the same meaning, as wellas to refer to hair loss generally, unless the context requiresotherwise. The term “trichological treatment” is used to refer to thetreatment and/or formulations for the treatment of alopecia and hairthinning in males and females. Although the term is used sometimes torefer to scalp conditions or the like, the invention is not limited totreatment of such conditions, and may be used to treat hair loss onother parts of the body.

There are several root causes of alopecia, some of which are wellestablished both clinically and pathologically, and quite wellunderstood. Other root causes are not well understood and/or subject ofconjecture. Some herbal and drug treatments of alopecia are directed toone or more of the root causes of alopecia, whether they be wellunderstood or merely conjectured. There is a quantity of research dataon efficacy, some of which is in conflict, indicating that the alopeciacondition is complex, and is probably affected by a range of differentmechanisms. Some root causes are expressed or exhibited more thanothers, but unless several of such root causes are addressed by aproposed remedy, it is suggested that its efficacy may be limited.

The present invention aims to provide formulations and treatments fortrichology which alleviate one or more of the shortcomings of the priorart. Other aims and advantages of the invention may become apparent fromthe following description.

DISCLOSURE OF THE INVENTION

With the foregoing in view, this invention in a first aspect residesbroadly in a formulation for trichological treatment including a 5-alphareductase production inhibitor and methylsulfonylmethane.

In a second aspect, the present invention resides broadly in aformulation for trichological treatment including:

a 5-alpha reductase production inhibitor;

methylsulfonylmethane; and

extract from the herbal variety Polygonum multiflorum.

In a third aspect, the present invention resides broadly in the presentinvention resides broadly in a formulation for trichological treatmentincluding:

a 5-alpha reductase production inhibitor;

methylsulfonylmethane;

extract from the herbal variety Polygonum multiflorum; and

colostrum.

In a fourth aspect, the present invention resides broadly in the presentinvention resides broadly in a formulation for trichological treatmentincluding:

a 5-alpha reductase production inhibitor;

methylsulfonylmethane;

extract from the herbal variety Polygonum multiflorum; and

levo-arginine.

In a fifth aspect, the present invention resides broadly in the presentinvention resides broadly in a formulation for trichological treatmentincluding:

a 5-alpha reductase production inhibitor;

methylsulfonylmethane;

extract from the herbal variety Polygonum multiflorum;

levo-arginine and

colostrum.

In a sixth aspect, the present invention resides broadly in the presentinvention resides broadly in a formulation for trichological treatmentincluding:

a 5-alpha reductase production inhibitor;

methylsulfonylnethane;

extract from the herbal variety Polygonum multiflorum;

levo-arginine;

colostrum; and

Gingko biloba.

In a seventh aspect, the present invention resides broadly in aformulation for trichological treatment including:

extract from the herbal variety Polygonum multiflorum;

a 5-alpha reductase production inhibitor;

methylsulfonylmethane; and

colostrum.

Preferably, the formulation includes zinc amino acid chelate. Preferablythe formulation includes Gingko biloba. More preferably, the formulationincludes both zinc amino acid chelate and Gingko biloba. It is furtherpreferred that the formulation includes any one or more extracts fromthe herbal varieties:

Polygonum multiflorum;

Gingko biloba;

Equisetum arvense;

Panax quinquefolium.

It is further preferred that the formulation includes any one or more ofthe following components:

one or more soy isoflavones;

levo-arginine;

inositol;

niacin;

biotin;

calcium pantothenate;

dextro-alpha-tocopherol;

Pyridoxine hydrochloride;

Preferably, the colostrum is bovine colostrum. However, it will beappreciated that other mammalian sources of colostrum may be used,particularly colostrum which are efficacious in ameliorating thereduction of growth hormone (“GH”) and/or insulin-like growth factor 1(“IGF-1”) with ageing. Preferably, the components are provided inrelative quantities selected to provide efficacy in respect of theirknown functional qualities. Preferably, the 5-alpha reductase productioninhibitor is selected from one or more phytosterols, particularly, asequivalents to beta-sitosterol. Alternatively, or in addition thereto,the 5-alpha reductase production may inhibitor may include extract fromSerenoa repens, or Saw palmetto. The herbal extracts may also includePygeum repens. The formulation may also include thiamine. Theformulation may also include riboflavin.

In an eighth aspect, the present invention resides broadly in aformulation for trichological treatment of a patient including, in adosage in the range of 3 g to 8 g:

phytosterols in the range of 200 mg to 2500 mg;

the quantitative equivalent of Polygonum multiflorum root 4:1 in 70% EWin the range of 600 mg to 2600 mg;

methylsulfonylmethane in the range of 500 mg to 2000 mg; and

bovine colostrum in the range of 500 mg to 2000 mg.

Preferably, the formulation further includes the quantitative equivalentof Gingko biloba leaf extract 50:1 in 70% EW in the range of 50 mg to1000 mg. Preferably, the formulation further includes the quantitativeequivalent of zinc amino acid chelate 20% in the range of 10 mg to 40mg. More preferably, the formulation includes both the Gingko biloba andthe zinc amino acid chelate. It is also preferred that the formulationincludes any one or more of the following components:

arginine in the range of 120 mg to 500 mg;

biotin in the range of 0.7 mg to 5 mg;

nicotinic acid in the range of 5 mg to 30 mg;

calcium pantothenate in the range of 10 mg to 400 mg;

pyridoxine hydrochloride in the range of 10 mg to 400 mg;

d-α-tocopherol acetate in the range of 200 IU to 800 IU; and

colloidal anhydrous silica in the range of 60 mg to 500 mg.

It is also preferred that the formulation also include any one or moreof the following components:

the quantitative equivalent of Glycine Max (soy) seed 65:1 in 75% EW inthe range of 80 mg to 3250 mg;

the quantitative equivalent of Panax quinquefolium root extract 3:1 in15% EW in the range of 50 mg to 1000 mg;

the quantitative equivalent of Equisetum arvense herb extract 4:1 in100% water in the range of 50 mg to 1000 mg;

inositol in the range of 70 mg to 300 mg;

Preferably, the phytosterols are in the range of 200 mg to 2500 mg. Morepreferably, the phytosterols are in the range of 200 mg to 1000 mg.Preferably, the Gingko biloba extract is in the range of 50 mg to 1000mg. More preferably, the Gingko biloba extract is in the range of 50 mgto 500 mg. Preferably, the Panax quinquefolium root extract is in therange of 50 mg to 1000 mg. More preferably, the Panax quinquefolium rootextract is in the range of 50 mg to 500 mg. Preferably, the Equisetumarvense herb extract is in the range of 50 mg to 1000 mg. Morepreferably, the Equisetum arvense herb extract is in the range of 50 mgto 500 mg. Preferably, the bovine colostrum is in the range of 50 mg to2000 mg. More preferably, the bovine colostrum is in the range of 500 mgto 1000 mg. Preferably, the biotin is in the range of 0.7 mg to 3 mg.Preferably, the pyridoxine hydrochloride is in the range of 100 mg to400 mg. Trusil natural lemon/lime in the range of 6 to 26 mg or aflavouring agent equivalent thereto may also be added to theformulation. Fructose in the range of 125 mg to 500 mg or a sweeteningagent equivalent thereto may also be added to the formulation.

In a ninth aspect, the present invention resides broadly in aformulation for trichological treatment of a patient including:

a for promoting the anagenic phase of hair growth and/or minimising thecatagenic and/or telegenic phases of hair growth;

a biological sulfur nutritional supplement for providing biologicallyactive sulfur;

one or more dihydrotestosterone blocking components for inhibiting thebinding of dihydrotestosterone to receptor sites and/or inhibits theaction of 5-alpha-reductase in converting testosterone todihydrotestosterone;

one or more capillary blood-flow promoters for promoting capillary bloodflow;

a growth factor component for promoting cell growth by ameliorating thereduction of growth hormone (“GH”) and/or insulin-like growth factor 1(“IGF-1”) with ageing;

an amino acid component having at least some of all of the essentialamino acids for human metabolism; and

a mineral component for introducing at least the minerals silicon andzinc into the patient.

Preferably, the formulation includes a vitamin component having at leastsome vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B8, vitaminB_(x), and vitamin E.

Preferably, the components are selected from the phytosterols, Polygonummultiflorum root, Glycine Max (soy) seed,Gingko biloba leaf, Panaxquinquefolium root, Equisetum arvense, inositol, methylsulfonylmethane,bovine colostrum, arginine, biotin, nicotinic acid, calciumpantothenate, pyridoxine hydrochloride, d-α-tocopherol acetate, Trusilnatural lemon/lime or a flavouring agent equivalent thereto, fructose ora sweetening agent equivalent thereto, colloidal anhydrous silica andzinc amino acid chelate to make up a dosage in the range of 2 g to 10 gas set forth in the eighth second aspect of the invention describedherein.

In a tenth aspect, the present invention resides broadly in a method oftreatment of hair loss in humans including the steps of:

preparing a first formulation for topical application to at least someof the skin of a human patient, the first formulation consisting of:extract from the herbal variety Polygonum multiflorum, methyl sulfonylmethane; a 5-alpha reductase production inhibitor; and colostrum;

preparing a second formulation for ingestion by the human patient, thesecond formulation consisting of: extracts from the herbal varieties ofPolygonum multiflorum, phytosterols, Gingko biloba, Equisetum arvenseand Panax quinquefolium; methylsulfonylmethane; soy isoflavones;levo-arginine; inositol; biotin; niacin; calcium pantothenate;dextro-alpha-tocopherol; pyridoxine hydrochloride; zinc amino acidchelate and colostrum.

Preferably, the first formulation further includes one or more of thecomponents: methylsulfonylmethane; Polygonum multiflorum (fo-ti root);grape seed oil; hawthorne herb; colostrum; beta sitosterol; primroseoil; flaxseed oil; cayenne pepper; L-arginine; silica; Gingko bilobaleaf extract and zinc sulfate, in relative quantities selected toprovide efficacy in respect of their known functional qualities.

The formulations so prepared are then used in the manner suggested abovein that the first formulation is applied to the skin, typically thescalp, of the patient and in close time proximity to such application,the second formulation is ingested by the patient. Typically, a dosagein the range of 2 to 8 g is efficacious. More preferably, the dosage isin the range of 5 to 6 g.

In an eleventh aspect, the present invention resides broadly in a methodof treatment of hair loss in humans including the steps of:

preparing a predetermined quantity of a first formulation for systemicuse, the first formulation consisting of: a hair growth component forpromoting the anagenic phase of hair growth and/or minimising thecatagenic and/or telegenic phases of hair growth; a biological sulfurnutritional supplement for providing biologically active sulfur; one ormore dihydrotestosterone blocking components for inhibiting the bindingof dihydrotestosterone to receptor sites and/or inhibiting the action of5-alpha-reductase in converting testosterone to dihydrotestosterone; oneor more capillary blood-flow promoters for promoting capillary bloodflow; a growth factor component for promoting cell growth byameliorating the reduction of growth hormone (“GH”) and/or insulin-likegrowth factor 1 (“IGF-1”) with ageing; an amino acid component having atleast some of all of the essential amino acids for human metabolism; amineral component for introducing at least the minerals silicon and zincinto the patient; and a vitamin component having at least some vitaminB1, vitamin B2, vitamin B3, vitamin B5, vitamin B8, vitamin B_(x), andvitamin E;

preparing a predetermined quantity of a second formulation for topicalapplication, the second formulation consisting of: a hair growthcomponent for promoting the anagenic phase of hair growth and/orminimising the catagenic and/or telegenic phases of hair growth; a hairgrowth component complement for complementing the functional qualitiesof the hair growth component; a metabolism-balancing component forbalancing the metabolism of the patient; a 5-alpha reductase productioninhibitor for inhibiting the patient's production of 5-alpha reductase;an amino acid complement providing substantially all of the amino acidsrequired for metabolism of the patient; a nitric oxide metabolite fromwhich nitric oxide may be produced in the metabolic processes of thepatient; a keratinocyte cell supplement for supplementing nutrients forthe patient's keratinocyte cells; a carbohydrate metabolism facilitatorfor facilitating carbohydrate metabolism of the patient; a hair cortexelasticity component for enhancing the elasticity of the hair corticesof the patient; an enzymatic antioxidant and detoxifying component fordetoxifying the patient, including the scavenging of oxidants; a mineralanti-oxidant component for supplementing the enzymatic antioxidant anddetoxifying component; and an immunoglobulin and growth-factorsupplement for supplementing the patient's intake of immunoglobulin andgrowth factor.

Preferably, the hair growth component includes a herbal extract fromPolygonum multiflorum. Preferably, the hair growth complement is in theform of a sulfur metabolite such as dimethyl sulfone(methylsulfonylmethane). Preferably, the blood flow enhancementcomponent includes a herbal extract of Gingko biloba. Preferably, thesilica metabolite includes a herbal extract of Equisetum arvense.Preferably, the metabolism-balancing component for balancing themetabolism of the patient includes a herbal extract of Panaxquinquefolium (American ginseng). The metabolism-balancing componentpreferably includes efficacy in normalising system levels in the body.American ginseng has been used to stimulate the immune system, lowercholesterol and increase energy levels. The 5-alpha reductase productioninhibitor may include a herbal extract of Serenoa repens (Saw Palmetto)or more preferably, phytosterols (equivalent to beta-sitosterol).Preferably, the amino acid complement has substantially all of the aminoacid essential for human metabolism. For example, a preferred amino acidcomplement includes soy isoflavones. Preferably, the nitric oxidemetabolite includes 1-arginine. Preferably, the keratinocyte cellsupplement includes inositol. Preferably, the carbohydrate metabolismfacilitator for facilitating carbohydrate metabolism of the patientincludes niacin. It is believed that niacin is essential for themetabolism of carbohydrate. Preferably, the hair cortex elasticitycomponent includes biotin. More preferably, the biotin and niacin, beingpart of the vitamin B-complex family, are included with other vitaminB-complex vitamins, such as riboflavin, pantothenic acid and the like.Preferably, pantothenic acid is positively included in the secondformulation in the form of a calcium salt. It is also preferredpyridoxine hydrochloride (vitamin B6) be included with the B-complexvitamins. Preferably, the enzymatic antioxidant and detoxifyingcomponent includes dextro-alpha-tocopherol (vitamin E). Preferably, themineral anti-oxidant component includes zinc, more preferably zinc aminoacid chelate. Preferably, the immunoglobulin and growth-factorsupplement includes colostrum. More preferably, the immunoglobulin andgrowth-factor supplement includes bovine colostrum.

While the formulation has been found to have increased efficacy whenused with both the topical and the systemic modes of delivery, it willbe appreciated that the method of the invention is not limited to theinclusion of both modes of delivery of one or more of the formulationsaccording to the invention.

Preferably, at least one of the capillary blood-flow promoters isfunctional in use to promote opening of potassium channels in cellmembranes of patients. Preferably, the amino acid component includesisoflavones and/or phytosterols. More preferably, the amino acidcomponent includes a phytoestrogen. More preferably, the amino acidcomponent includes Genistein. In another preferred form, the amino acidcomponent includes Daidzien. The vitamin and mineral components may beconstituted from one or more sources. For example, the silicon mineralmay be derived from the herb known as horsetail, Equisetum arvense. Thezinc mineral may be contained in a zinc citrate or the like.

Preferably, preparation of the formulation for ingestion includesforming the components into respective component powders, mixing thecomponent powders together and packaging the powder into predetermineddosage packs. One preferred dosage pack contains the mixed powder in therange of 3 g to 9 g powder. In a particular preferred form, the dosageis 5.5 g powder. In such form, it is preferred that the mixed powder beingested in a drink, such as water, but it will be appreciated that awide range of potable liquids would be suitable. It is suggested that amonthly supply of 200 g to 1000 g powder is efficacious when taken inaccordance with the method of the invention. Of course, colouring and/orflavouring additives may be included, as well as dispersing and/oremulsifying agents, thickeners, preservatives or the like.

The powder may be formed so as to have different flavourings and/orcolourings. Moreover, the powder may be flavoured differently fordifferent diluents, such as, for example, a fruit-type flavour formixing in water and a vanilla, chocolate or caramel flavour for mixingin milk or non-dairy equivalents of milk.

Preferably, the preparation of the formulation for topical applicationincludes forming the components into respective component powders,mixing the component powders together and mixing, folding, blending orcombining the powders into a paste formed with liquid, such as oil,water or such like to such consistency that it can be delivered throughan eye-dropper. In a particular preferred form, the dosage is 0.5 to 5ml per application. For example, a paste may be prepared using alcoholas a diluent. Other oils, water and/or emulsifying agents may also usedin addition to or instead of the alcohol. It is suggested that themixture be formed into a flowable material of such consistency that itcan flow through an eye-dropper.

In a twelfth aspect, the present invention resides broadly in a serumformulation for trichological treatment of a patient including:methylsulfonylmethane; Polygonum multiflorum (fo-ti root); one or moreplant and/or seed oils; hawthorne herb; colostrum; beta sitosterol;cayenne pepper; L-arginine; Gingko biloba leaf extract and zinc sulfate,in relative quantities selected to provide efficacy in respect of theirknown functional qualities. Preferably, the serum includes silica.Preferably, the one or more plant and/or seed oils include any one, twoor all of the group selected from grape seed oil, primrose oil andflaxseed oil.

In a thirteenth aspect, the present invention resides broadly in amedicinal formulation for trichological treatment including:

extracts from the herbal varieties:

-   -   Polygonum multiflorum;    -   Gingko biloba;    -   Equisetum arvense;    -   Panax quinquefolium;

methylsulfonylmethane;

levo-arginine;

a 5-alpha reductase production inhibitor;

one or more soy isoflavones;

inositol;

niacin;

biotin;

calcium pantothenate;

dextro-alpha-tocopherol;

Pyridoxine hydrochloride;

zinc amino acid chelate; and

colostrum.

The constituents of the medicinal formulation are preferably selected insubstantially in accordance the limitations of correspondingconstituents of the other corresponding aspects of the invention asherein described.

BRIEF DESCRIPTION OF THE EXAMPLES

In order that the invention may be more readily understood and put intopractical effect, reference will now be made to one or more examples ofthe invention wherein at least some of the aspects and embodiments ofthe invention are described from experimental work in the development ofthe invention.

DETAILED DESCRIPTION OF THE EXAMPLES Example 1

A batch of material was formulated according to the details set forth inTable 1 below.

mg per g weight Ingredient (and Label (including for mix strength) Claimmg mg/dose overage overage) (kg) phytosterols (equiv. B- 500.00 303 15153% 312.09 35.344 sitosterol 33%) Polygonum 1350.00 67.5 337.5 5% 70.888.027 multiflorum (fo ti) root 4:1 in 70% EW Glycine max (soy) seed1625.00 5 25 0% 5.00 0.566 65:1 in 75% EW Gingko biloba leaf ext 100.000.4 2 5% 0.42 0.048 (50:1 in 70% EW) Panax quinquefolium 100.05 6.6733.35 5% 7.00 0.793 root ext (3:1 in 15% EW) Equisetum arvense herb100.00 5 25 5% 5.25 0.595 ext (horsetail) (4:1 in 100% water) inositol150.00 30 150 5% 31.50 3.567 methylsulfonylmethane 1000.00 200 1000 5%210.00 23.783 (MSM) colostrum (bovine) 1000.00 200 1000 5% 310.00 23.783arginine 250.00 50 250 0% 50.00 5.663 biotin 1.40 0.28 1.4 5% 0.29 0.033nicotinic acid 15.00 3 15 5% 3.15 0.357 calcium pantothenate 200.00 40200 4% 41.67 4.719 pyridoxine 25 5 25 5% 5.24 0.595 hydrochlorided-α-tocopherol acetate 400 IU 107.2 536 5% 112.56 12.747 (dry vitamin Eacetate) Trusil natural 13 2.6 13 5% 2.73 0.309 lemon/lime fructose 25050 250 0% 50.00 5.663 silica colloidal 125 25 125 0% 25.00 2.831anhydrous zinc amino acid chelate 20 20 100 5% 21.00 2.378 20% x Total6804.45 1120.65 5603.25 131.799

The resulting formulation was tested against a placebo on a number ofindividuals for hair loss. The test results revealed that theformulation was efficacious in the treatment of hair loss.

Example 2

A batch of material was formulated according to the details set forth inTable below.

LABEL CLAIM INGREDIENT (mg per 5 g serve) Mg Mg/Dose Phytosterols (EquivB-sitosterol 33%) 125.00 75.75 378.75 Polygonum multiflorum (Fo Ti) root4:1 in 70% 337.50 16.88 84.38 EW Glycine Max (Soy) seed 65:1 in 75% EW406.25 1.25 6.25 Ginkgo Biloba leaf ext (50:1 in 70% EW) 25.00 0.10 0.50Panax quinquefolium root ext (3:1 in 15% EW) 25.01 1.67 8.34 Equisetumarvense herb Ext (Horsetail) (4:1 in 25.00 1.25 6.25 100% Water)Inositol 37.50 7.50 37.50 Methylsulfonylmethane (MSM) 250.00 50.00250.00 Colostrum (Bovine) 250.00 50.00 250.00 Arginine 62.50 12.50 62.50Biotin 0.35 0.07 0.35 Nicotinic Acid 3.75 0.75 3.75 Calcium Pantothenate50.00 10.00 50.00 Pyridoxine Hydrochloride 6.25 1.25 6.25 d-alphatocopheryl acetate (Dry Vitamin E Acetate) 100 IU 26.80 134.00 TrusilNatural Lemon/Lime 3.25 0.65 3.25 Fructose 62.50 12.50 62.50 Silica -Colloidal Anyhydrous 31.25 6.25 31.25 Zinc Amino Acid Chelate 20% 5.005.00 25.00 Total 1706.11 280.16 1400.81

The resulting formulation was tested against a placebo on a number ofindividuals for hair loss. The test results revealed that theformulation was efficacious in the treatment of hair loss.

Example 3

A batch of material was formulated according to the details set forth inTable 3 below.

LABEL CLAIM INGREDIENT (mg per 5 g serve) Mg Mg/Dose Phytosterols (EquivB-sitosterol 33%) 250.00 151.50 757.50 Polygonum multiflorum (Fo Ti)root 4:1 in 70% 675.00 33.75 168.75 EW Glycine Max (Soy) seed 65:1 in75% EW 812.50 2.50 12.50 Ginkgo Biloba leaf ext (50:1 in 70% EW) 50.000.20 1.00 Panax quinquefolium root ext (3:1 in 15% EW) 50.03 3.34 16.68Equisetum arvense herb Ext (Horsetail) (4:1 in 100% Water) 50.00 2.5012.50 Inositol 75.00 15.00 75.00 Methylsulfonylmethane (MSM) 500.00100.00 500.00 Colostrum (Bovine) 500.00 100.00 500.00 Arginine 125.0025.00 125.00 Biotin 0.70 0.14 0.70 Nicotinic Acid 7.50 1.50 7.50 CalciumPantothenate 100.00 20.00 100.00 Pyridoxine Hydrochloride 12.50 2.5012.50 d-alpha tocopheryl acetate (Dry Vitamin E Acetate) 200 IU 53.60268.00 Trusil Natural Lemon/Lime 6.50 1.30 6.50 Fructose 125.00 25.00125.00 Silica - Colloidal Anyhydrous 62.50 12.50 62.50 Zinc Amino AcidChelate 20% 10.00 10.00 50.00 Total 3412.23 560.33 2801.63

The resulting formulation was tested against a placebo on a number ofindividuals for hair loss. The test results revealed that theformulation was efficacious in the treatment of hair loss.

Example 4

A batch of material was formulated according to the details set forth inTable 4 below.

LABEL CLAIM INGREDIENT (mg per 5 g serve) Mg Mg/Dose Phytosterols (EquivB-sitosterol 33%) 1000.00 606.00 3030.00 Polygonum multiflorum (Fo Ti)root 4:1 in 70% 2700.00 135.00 675.00 EW Glycine Max (Soy) seed 65:1 in75% EW 3250.00 10.00 50.00 Ginkgo Biloba leaf ext (50:1 in 70% EW)200.00 0.80 4.00 Panax quinquefolium root ext (3:1 in 15% EW) 200.1013.34 66.70 Equisetum arvense herb Ext (Horsetail) (4:1 in 200.00 10.0050.00 100% Water) Inositol 300.00 60.00 300.00 Methylsulfonylmethane(MSM) 2000.00 400.00 2000.00 Colostrum (Bovine) 2000.00 400.00 2000.00Arginine 500.00 100.00 500.00 Biotin 2.80 0.56 2.80 Nicotinic Acid 30.006.00 30.00 Calcium Pantothenate 400.00 80.00 400.00 PyridoxineHydrochloride 50.00 10.00 50.00 d-alpha tocopheryl acetate (Dry VitaminE Acetate) 800 IU 214.40 1072.00 Trusil Natural Lemon/Lime 26.00 5.2026.00 Fructose 500.00 100.00 500.00 Silica - Colloidal Anyhydrous 250.0050.00 250.00 Zinc Amino Acid Chelate 20% 40.00 40.00 200.00 Total13648.90 2241.30 11206.50

The resulting formulation was tested against a placebo on a number ofindividuals for hair loss. The test results revealed that theformulation was efficacious in the treatment of hair loss.

In use, the formulations and methods of the present invention may beused for the treatment of hair loss in a human patient. It is believedthat the formulations of the present invention, together with the methodof dual-mode treatment, contribute synergistically to provide enhancedresults of greater efficacy than either the individual components ormodes of treatment. It is believed that the formulation assists eitherin decreasing levels of dihydrotestosterone build-up or the blocking ofthis material at receptor sites. It is believed that the ingredients ofthe present invention all make a contribution to the potency of theformula. It is believed that all of the components independently havehair health benefits. The beneficial effects of the treatment arebelieved to include elimination, or reduction of the action ofdihydrotestosterone, remediation of incorrect flow or lack ofcirculation both peripheral and cardiovascular, reduction ofminiaturisation of the hair strand or incorrect hormonal or dietarybalance.

The fo-ti-root extract component may also be known as “He Shou Wu”. Itsbeneficial effects may be explained as follows: There are three stagesof hair growth, known as the anagen stage, being the active growthphase, the catagen stage, being the regressive phase and the telegenstage, being the resting phase. For humans, normally between 50 and 100hairs are shed everyday, whether male or female. A full head of thickhair is due to the rate of hair growth being greater or equal than therate of fall out. That having been said, fo-ti-root prolongs theanagenic stage or growth phase, while minimising the resting ortelegenic stage and catagenic or fall out stage. The Chinese herb knownas Ho Shou Wu (Polygoni multiflori or Radix polygoni) also known asfo-ti-root has been demonstrated clinically to be effective inmaximising hair growth stages for the benefit of hair preservation. Theliteral English translation for Ho Shou Wu is “black hair Mr Ho” thatspeaks for its ability to preserve natural hair colour, which is afurther benefit of long term usage. Chinese medicine follows the beliefthat the condition of the hair is an indication of the body's internalsystemic health. Fo-ti-root is thought to be a tonic for the endocrineglands, liver and kidneys. Fo-ti-root contains many vitamins andminerals that are vital for hair, including the b-complex vitamins,vitamin C, silicon, zinc and vitamin A.

So far as methylsulfonylmethane is concerned, prolongation of theanagenic phase of hair growth is effected when this material works tocomplement fo-ti-root's aforesaid functional qualities.Methylsulfonylmethane has been called “nature's beauty mineral” becauseit is believed to keep the hair glossy and smooth, keeps the complexionclear and youthful, and is believed to contribute to the synthesiscollagen. This material is prevalent in keratin, a tough proteinsubstance necessary for the health and maintenance for the hair, nailsand skin. Some of the functional qualities of methylsufonymethaneinclude improved micro-circulation to the hair and scalp, maintainingstructure of the proteins in the body, helping the formulation ofkeratin and aiding in the production of immunoglobulin. Keratin isessential for hair and nail growth and immunoglobulin maintains theimmune system.

Insofar as beta sitosterol is concerned, this material can be derivedfor example from Saw Palmetto (Serenoa Repens), a native American memberof the palm family. Saw palmetto is a source of a class of complex,chiefly unsaturated, solid alcohols widely distributed in plant ananimal tissue, known as sterols. More specifically, plants containphytosterols, or plant based sterols. Sitosterols are sterols that arefound in food (sito=food). Sitosterols have been shown to slow theproduction of 5-alpha reductase and the binding of dihydrotestosteroneto androgen receptors. Research has shown that dihyrdotestosterone is aprinciple cause of hair loss, and undesirable derivative of theandrogenic hormone testosterone. Dihydrotestosterone floods andeventually strangles the hair follicles of genetically predisposedindividuals. The key to anti-androgenic complex lies in eliminating theroot cause of hair loss by blocking dihydrotestosterone at the folliclereceptor site. It is believed that beta-sitosterol (stigmast-6-en-3β-ol)is a multi-site inhibitor of the formation and actions ofdihydrotestosterone, inhibiting most of the binding of thedihydrotestosterone, to receptor sites, blocking the up take ofdihydrotestosterone and inhibiting the action of 5-alpha-reductase,which converts testosterone to dihydrotestosterone. Pygeum africanum isanother natural source of beta-sitosterol. Although there are somepharmaceutical substances which are used to treat hair loss and are ableto block the conversion of testosterone to dihydrotestosterone, many ofthese have undesirable side effects including reduced sex drive andbirth defects.

Insofar as ginkgo biloba is concerned, this herbal extract has a longstanding tradition for use in providing natural vascular benefits wheningested or applied topically. Gingko biloba has been shown to protectsmall blood vessels and micro capillaries against loss of tone andincrease in fragility. Because the action of dihydrotestosterone causesinflammation of follicle blood supply, a major factor in male and femalepattern hair loss, Gingko biloba is beneficial and due to its functionalquality of dilating blood vessels (particularly small blood vessels) andhas particular ability to increase peripheral blood circulation,especially to the brain. Gingko biloba is believed to have beneficialeffects in preventing many conditions throughout the entire body due topoor blood supply. Gingko biloba can also act as a powerful anti oxidantand may contribute to the oxidation of free radicals, which are believedto contribute to premature aging. Anti oxidants also protect the eyes,cardiovascular system and central nervous systems. In traditionalChinese medicine, Gingko biloba has been used to improve the heart andcirculation. The herb has been used for many centuries by the Chinese,and has become a conventional supplement in Europe, and more recently,in the United States.

L-arginine is an amino acid, one of the building blocks of protein.However, in the present application, L-arginine serves as a precursor inthe body for the production of nitric oxide, believed to have a criticalrole in human metabolism, and believed to be produced by the linings ofthe blood vessels known as the vascular endothelium. Because nitricoxide lasts only for a few seconds once produced, its discovery wasparticularly illusive, but once found, researchers appreciated that thiswas probably the mysterious molecule that controlled blood vesseldilation. L-arginine is an essential amino acid and one of the mostimportant supplements available to improve circulation and blood vesselhealth. It is believed that nitric oxide causes blood vessels to relax,opening them up and promoting easy blood flow. The reason that nitricoxide is of interest in the present application, is that where hair lossand growth are concerned, vessel dilators are believed to play a role instimulating hair growth. Nitric oxide is believed to be a critical linkin the hair growth process and it appears that nitric oxide may beinvolved in opening potassium channels known as “K-Channels”. L-argininehas been shown to promote natural growth hormone (GH)release frompituitary gland. GH has been shown to support a healthy lifestyle andmay minimise a related decline. This material may also assist in kidneycontrol of solubles in the body.

Insofar as colostrum in concerned, it is a material produced by nearlyall mammals, by the mother of the offspring soon after birth. Medicalresearch has shown that the most important immune and growth factors forhuman adults, children and animals can be provided by bovine colostrum.Because colostrum is a food rather than a drug it is free of toxicityand can be consumed without any known side effects. Colostrum researchconducted by major medical centres and universities has shown clinicallyactive bovine supplements derived from dairy cows naturally stimulatesthe nutrient-rich properties that a mother produces for her new-bornoffspring just after birth. Colostrum provides a supercharged blend ofvital proteins, antibodies, anti-oxidants, immunoglobulin, growthfactors, vitamins, minerals, enzymes and amino acids. The highly chargednature of colostrum precludes it being produced at sustained levelsthroughout the lactation of a mammalian parent. However, its initialproduction soon after parturition is provided by nature to give an earlyboost to the new born mammalian offspring. Colostrum is also believed tohave the functional quality of combating and even reversing signs ofaging.

In so far as Soy isoflavones are concerned, soy and most soy basedproducts are believed to be the only plant food that has all theessential amino acids required of the human body, making it a “completeprotein source”. Soy foods generally do not have any cholesterol andmost are high in fibre. In addition, soy has many vitamins, minerals andphyto-chemical compounds (like isoflavones) that work together to createnumerous health benefits. Soy isoflavones are plant substances which arebelieve to contribute to hormonal balance when included as a dietarysupplement. Soy products also include phytosterols. Soy isoflavones andphytosterols are known to supply mild estrogenic effects. The soyisoflavones, rich in phyto-nutrients, help prevent medic conditionsassociated with aging and from the large body of research can have apositive effect on hair for woman as well as for men. Soy beans containphyto-estrogens, Genistein being one, which has been shown to havesignificant 5-alpha-reductase blocking activity, and androgen modulatingactivity. Another phyto-estrogen from soy beans, Daidzien, also helpsblock the 5-alpha-reductase enzyme. It is believed that this materialmay also reduce the risk of heart disease. Soy bean products have beenshown to lower LDL (“Bad”) cholesterol, and significantly increase HDL(“good”) cholesterol.

Silica (horsetail herb) is believed to be the best and most concentratedplant source of the mineral silica for its introduction into the foodchain. Silica is an important component of hair, nail, skin, bones,ligaments and collagen and is an essential herb needed for the physicalintegrity of these structures. Silica enhances the absorption of allminerals in the body. It has the effect of strengthening hair folliclesand stimulates and increases growth of hair. Silica tends to decline ashumans age. This decline can be responsible for many complaintsassociated with aging, and conditions have been linked to silica such asdry hair, hair loss, dry skin, weak brittle hair and nails, nervousness,poor energy levels and the like. Weak bone structure silica maximisesthe absorption of calcium by the bones, may be strengthened and takinghorsetail has been clinically shown to help fractured and broken bonesheal more quickly. Grains and cereal produced by modem farming practicestend to be depleted of nutrients and silica. It is believed that veryfew foods have a high enough silica content to supply human dietaryneeds. Horsetail is rich silicic acid and silicates which provideapproximately 2-3% elemental silicone. The high concentration of silicain horsetail is highly absorbable and utilised to facilitate calciumabsorption, thereby promoting hair and bone growth and collagenformation. The herb also contains potassium, aluminium, manganese,calcium and 15 types of bioflavonoid. Horsetail also supports theskeletal system strengthening bones and connective tissues. Silicic acidcontained in horsetail is believed to help improve circulation and buildthe immune nervous systems.

The nutrient inositol is believed to be essential for keratinocyte, thecells which line the hair follicles and produce hair. Inositol is anessential component of the b vitamin group and is often referred to asVitamin B8. Hair loss often occurs when the diet is inadequate in BVitamins—especially vitamin B6, inositol, biotin and folic acid, and theminerals sulphur and zinc. The B group vitamins, especially inositol, B5(pantothenic acid) and B3 (niacin or nicotinamide) are especiallyimportant for hair growth. In the field of nutrition, well-being andhealth, inositol has an important part to play, not only being requiredfor optimal general help, but also has specific functions in the body inwhich it assists. Examples of these functions include hair growth,calming effect, lowering cholesterol and lecithin. The body inositollevels can be depleted by caffeine, sulfonamide and excess water.Inositol is found in lecithin, whole grains, citrus fruit, liver,brewers yeast, vegetables, black strap molasses, soy beans and the like.The B group vitamins are important factors for proper maintenance of thenervous system, proper functioning of the cell and its energymetabolism. Any kind of mental and physical stress as well as pooreating habits greatly increase the bodies need for B group vitamins.Since B group vitamins are water soluble, they are not stored and mustbe supplied as the body needs them on a regular basis. Inositol is alsobelieved to be a hydroxyl radical, and is believed to be essential foroverall growth and preventing the thinning and greying of hairassociating with aging.

Zinc is an essential mineral for body metabolism and has a myriad ofhealth benefits for the human body. As far as the hair and scalp areconcerned, it has been shown that zinc in high concentrations couldcompleting inhibit the 5-alpha-reductase activity and that the vitaminB6 potentiated the inhibitory effect of zinc. Zinc is believed tostimulate the activity of approximately 100 enzymes, substances whichpromote biochemical reactions in the body. Zinc supports normal growthand a healthy immune system. The mineral also helps to protect cellsagainst oxidative damage, safeguard red blood cell membranes againstoxidative effects against of other minerals such as copper and iron,keeps cell membrane contents in place and selectively allows salts andother components to flow in and out of cells. Zinc is present in suchfoods as beans, whole grains, shellfish, red meat, dark meat, poultryand the like.

Vitamin E has been shown to retard cellular aging due to oxidation, theeffect of maintaining peripheral circulation, is one of the moreimportant anti oxidants, the strong presence of vitamin E being linkedto longevity, reducing the effects of oxidated stress, and is a vitalpart of the formula involved in retarding cellular aging. Vitamin E is anatural detoxifier of impurities within the metabolic system of thebody. It increases blood circulation for healthy hair growth but, as itcant be stored in the body, deficiencies can occur without a personbeing aware of it. It is essential for the body growth of body tissuecells and blood vessels. Longer living humans have been found to havehigher amounts of vitamin E in their brain tissues.

Each member of the B vitamin group has a unique structure and performs aunique function in the human body. Vitamins B1, B2, B3 and biotinparticipate in different aspects of energy production, vitamin B6 isessential for amino acid, metabolism, and folic acid facilitates stepsrequired for cell division. Each of these vitamins has many additionalfunctions. Biotin is believed to increase elasticity of the hairs cortexpreventing breakage and also thickens actual hair cuticle providing afuller appearance and sounder result as a result of the increasediameter of the hair shaft. Biotin is sometimes referred to as VitaminH, however it is generally accepted as being one of the B groupvitamins. The vitamin promotes hair growth, protects against dryness, isinvolved in bio synthesis of unsaturated fats and is needed for energymetabolism. Folic acid is a water soluble B complex vitamin which assistwith hair and tissue growth and cell functions. Para aminobenzoic acidis one of the lesser known members of the B complex family. It has beenshown to be an anti grey hair vitamin. The vitamin has been shown torestore normal hair colour, and other research indicates this can alsobe done when combined with folic acid. This substance is commonly usedin sunscreens. In so far as the other vitamin B's are concerned, VitaminB1 (thiamine) has a role in the development of blood cells and themaintenance of hair and scalp and muscle tissue. Vitamin B2 (riboflavin)is involved in energy metabolism, and supports vision, hair and skinhealth. Vitamin B3 (niacin) is essential for the metabolism ofcarbohydrates, fat and alcohol, it helps maintain skin health andsupport the nervous and digestive systems. Pantothenic acid isconsidered to be important to the health of the skin and scalp, isnecessary for the well being of every body cell and neither carbohydratenor fat can be changed into energy without it. This nutrient is obtainedfrom liver, kidney, egg yolks, whole grains, milk and potatoes. Thecombined effects of the materials used to formulate the formulation ofthe present invention are believed to provide trichological benefitseffects in stopping and preventing dihydrotestosterone, the cause ofhair loss and hair thinning in men and woman, as well as other effects.Panax quinquefolium root extract is also known by some as ginseng, atraditional herbal remedy from Asia, and used extensively in Asiancultures.

Although the invention has been described with reference to specificexamples, it will be appreciated by persons skilled in the art that theinvention may be embodied in other forms which are encompassed withinthe broad scope and ambit of the invention as herein set forth.

1-61. (canceled)
 62. A formulation for trichological treatmentincluding: a 5-alpha reductase production inhibitor selected from one ormore phytosterols as equivalents to beta-sitosterol;methylsulfonylmethane; extract from the herbal variety Polygonummultiflorum; levo-arginine; colostrum; and Gingko biloba.
 63. Theformulation for trichological treatment according to claim 62, whereinthe formulation includes zinc amino acid chelate.
 64. The formulationfor trichological treatment according to claim 62 or claim 63, whereinthe formulation includes any one or more extracts from the herbalvarieties: Polygonum multiflorum; Gingko biloba; Equisetum arvense;Panax quinquefolium.
 65. The formulation for trichological treatmentaccording to claim 64, wherein the formulation includes any one or moreof the following components: one or more soy isoflavones; levo-arginine;inositol; niacin; biotin; calcium pantothenate; dextro-alpha-tocopherol;Pyridoxine hydrochloride;
 66. The formulation for trichologicaltreatment according to claim 62, wherein the colostrum is bovinecolostrum.
 67. The formulation for trichological treatment according toclaim 62, wherein the 5-alpha reductase production includes extract fromSerenoa repens.
 68. The formulation for trichological treatmentaccording claim 62, and including Pygeum repens.
 69. The formulation fortrichological treatment according to claim 62, and including thiamine.70. The formulation for trichological treatment according to claim 62,and including riboflavin.
 71. A formulation for trichological treatmentof a patient including, in a dosage in the range of 3 g to 8 g:phytosterols as equivalents to beta-sitosterol in the range of 200 mg to2500 mg; the quantitative equivalent of Polygonum multiflorum root 4:1in 70% EW in the range of 600 mg to 2600 mg; methylsulfonylmethane inthe range of 500 mg to 2000 mg; bovine colostrum in the range of 500 mgto 2000 mg; and the quantitative equivalent of Gingko biloba leafextract 50:1 in 70% EW in the range of 50 mg to 1000 mg.
 72. Aformulation for trichological treatment according to claim 71, andfurther including the quantitative equivalent of zinc amino acid chelate20% in the range of 10 mg to 40 mg.
 73. The formulation fortrichological treatment according to claim 71 or claim 72, and includingany one or more of the following components: arginine in the range of120 mg to 500 mg; biotin in the range of 0.7 mg to 5 mg; nicotinic acidin the range of 5 mg to 30 mg; calcium pantothenate in the range of 10mg to 400 mg; pyridoxine hydrochloride in the range of 10 mg to 400 mg;d-a-tocopherol acetate in the range of 200 Hi to 800 IU; and colloidalanhydrous silica in the range of 6O mg to 500 mg.
 74. The formulationfor trichological treatment according to claim 71, and including any oneor more of the following components: the quantitative equivalent ofGlycine Max (soy) seed 65:1 in 75% EW in the range of 80 mg to 3250 mg;the quantitative equivalent of Panax quinquefolium root extract 3:1 in15% EW in the range of 50 mg to 1000 mg; the quantitative equivalent ofEquisetum arvense herb extract 4:1 in 100% water in the range of 50 mgto 1000 mg; inositol in the range of 70 mg to 300 mg;
 75. Theformulation for trichological treatment according to claim 71, whereinthe phytosterols are in the range of 200 mg to 2500 mg.
 76. Theformulation for trichological treatment according to claim 71, whereinthe phytosterols are in the range of 200 mg to 1000 mg.
 77. Theformulation for trichological treatment according to claim 71, whereinthe Gingko biloba extract is in the range of 50 mg to 1000 mg.
 78. Theformulation for trichological treatment according to claim
 71. whereinthe Gingko biloba extract is in the range of 50 mg to 500 mg.
 79. Theformulation for trichological treatment according to any one of claim74, wherein the Panax quinquefolium root extract is in the range of 50mg to 1000 mg.
 80. The formulation for trichological treatment accordingto claim 74, wherein the Panax quinquefolium root extract is in therange of 50 mg to 500 mg.
 81. The formulation for trichologicaltreatment according to claim 74, wherein the Equisetum arvense herbextract is in the range of 50 mg to 1000 mg.
 82. The formulation fortrichological treatment according to claim 74, wherein the Equisetumarvense herb extract is in the range of 50 mg to 500 mg.
 83. Theformulation for trichological treatment according to claim 71, whereinthe bovine colostrum is in the range of 50 mg to 2000 mg.
 84. Theformulation for trichological treatment according to claim 73, whereinthe bovine colostrum is in the range of 500 mg to 1000 mg.
 85. Theformulation for trichological treatment according to claim 73, whereinthe biotin is in the range of 0.7 mg to 3 mg.
 86. The formulation fortrichological treatment according to claim 73, wherein the pyridoxinehydrochloride is in the range of 100 mg to 400 mg.
 87. A medicinalformulation for trichological treatment including: extracts from theherbal varieties: Polygonum multiflorum; Gingko biloba; Equisetumarvense; Panax quinquefolium; methylsulfonylmethane; levo-arginine; a5-alpha reductase production inhibitor; one or more soy isoflavones;inositol; niacin; biotin; calcium pantothenate; dextro-alpha-tocopherol;pyridoxine hydrochloride; zinc amino acid chelate; and colostrum.